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EB

Enveric Biosciences, Inc. (ENVB)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 focused on advancing EB-003 and expanding IP, with net loss improving year over year and cash strengthened by a $5M offering; management now targets filing the EB-003 IND by end of Q1 2026, a delay versus prior expectations .
  • No revenue reported; operating spend decreased versus prior year with lower G&A, while R&D rose driven by consulting activity; loss per share improved to $(1.22) from $(9.21) YoY due to share count changes and lower operating expenses .
  • Guidance effectively shifted from “H2 2025 IND filing” (Q3 2024) to “end of Q1 2026,” indicating additional preclinical and regulatory preparation; management emphasized confidence in EB-003 and expanding IP (EVM401) .
  • Liquidity improved quarter-over-quarter on financing, but management disclosed substantial doubt about going concern absent additional capital; an ATM program up to ~$1.85M was added in April to extend runway .
  • No Q1 2025 earnings call transcript was available; therefore, no Q&A themes; consensus estimates from S&P Global were unavailable for ENVB this quarter, so no beat/miss assessment versus Street [GetEstimates Q1 2025 returned no data].

What Went Well and What Went Wrong

What Went Well

  • EB-003 development progressed with supportive preclinical data showing oral bioavailability, brain exposure, and receptor engagement; management highlighted confidence in non-hallucinogenic neuroplastogen strategy .
  • IP expansion: Notice of Allowance for EB-003 composition of matter and issuance of a U.S. patent for the EVM401 Series of mescaline derivatives broaden pipeline options .
  • Business development: Two licensing agreements with Restoration Biologics for cannabinoid-COX-2 conjugates, creating potential diversified future revenue streams through milestones and royalties .

What Went Wrong

  • IND timing pushout: target moved from H2 2025 (Q3 2024 disclosure) to end of Q1 2026, implying extended preclinical/regulatory work and potential timeline risk .
  • Going concern risk: despite cash of $4.29M at quarter end, management stated substantial doubt about continuing as a going concern without additional financing; ATM established but modest size (~$1.85M) .
  • No revenue and continued losses: net loss of $2.18M; R&D rose 47% YoY due to consulting and the absence of last year’s Australian R&D tax incentive gain, increasing reliance on external capital .

Financial Results

Consolidated P&L and Cash (no segment revenue; single operating segment)

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD)$0.00 $0.00 $0.00
Total Operating Expenses ($USD)——$2.19M
Loss from Operations ($USD)——$(2.19)M
Net Loss ($USD)$(2.10)M $(3.20)M $(2.18)M
Diluted EPS ($USD)$(0.24) $(4.83) $(1.22)
Cash & Equivalents ($USD)$3.10M $2.20M $4.29M

Notes:

  • ENVB reported no revenue in these periods; statements of operations reflect operating expenses and losses without a revenue line .
  • Prior quarter and prior year comparables drawn from company 8-Ks and 10-Q.

Operating Expense Detail

MetricQ1 2024Q1 2025
General & Administrative ($USD)$1.89M $1.36M
Research & Development ($USD)$0.51M $0.75M
Depreciation & Amortization ($USD)$0.09M $0.08M
Total Operating Expenses ($USD)$2.48M $2.19M

Capitalization and Share Data

MetricQ4 2024Q1 2025
Shares Outstanding (period end)678,002 2,471,656
Weighted Avg Shares (Basic & Diluted)266,764 (Q1 2024) 1,797,774 (Q1 2025)
Warrants Outstanding56,308 (12/31/24) 3,481,267 (3/31/25)
Working Capital ($USD)—$3.65M (3/31/25)

Segment breakdown: Company operates as a single segment; no segment revenue disclosed .

KPIs: ENVB is pre-revenue; management emphasizes EB-003 IND preparation, IP expansion (EVM301/EB-003; EVM401), and out-licensing milestones/royalties potential .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EB-003 IND filing targetDevelopment timeline“IND in H2 2025” (Q3 2024) “IND by end of Q1 2026” (Q1 2025) Lowered (timing delayed)
Funding strategy2025Equity raises as needed (ongoing)$5M public offering closed Feb 3, 2025; ATM up to ~$1.85M initiated Apr 9, 2025 New financing executed/available

No formal financial guidance (revenue, margins, tax rate, OpEx, dividends) was issued in Q1 materials -.

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available; themes derived from recent filings/press releases.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Regulatory/IND timelineIND “anticipated H2 2025”; preclinical safety and pharmacology supportive -Pre-IND planning; reiterated advancement path; market opportunity case -IND targeted “end of Q1 2026”; continued preclinical data generation Slower timeline; extended preparation
R&D execution (EB-003)Oral bioavailability, brain exposure; receptor selectivity; non-hallucinogenic profile -Additional preclinical confirmation; safety pharmacology; presentation of data -Ongoing preclinical work and data accumulation; IND package build Steady progress
IP expansionAnnounced 5 additional U.S. patents (EVM301) Notice of Allowance for EB-003; broadened IP NOA for EB-003; patent issuance for EVM401 series Strengthening IP
Business developmentLicensing (Aries; MycoMedica) Additional licensing (Aries; MycoMedica; Restoration Biologics) Two Restoration Biologics licenses; potential milestones/royalties Building non-core monetization
Liquidity/capitalEquity activities; warrants; distribution agreement (2024) $5M offering closed; cash $2.2M Cash $4.29M; going concern risk; ATM up to ~$1.85M Runway improved but constrained
Macro/regulatory risksPsychedelic approval complexities; design considerations Emphasis on outpatient label potential Broader risk disclosures incl. tariffs/macro -Stable risk set disclosure

Management Commentary

  • “We continue to focus our development efforts on the completion of the data package to support filing an Investigational New Drug (IND) application for EB-003, which we aim to submit to the FDA by the end of the first quarter of 2026.” — CEO Joseph Tucker .
  • “Ongoing development of EB-003 is supported by the data accumulated to date, which have demonstrated oral bioavailability and brain exposure in preclinical studies.” — CEO Joseph Tucker .
  • “Enveric is entering 2025 with a clear mission – enhance shareholder value by cementing our leadership position in the promising neuroplastogen field with the continued development of EB-003.” — CEO Joseph Tucker .
  • “Enveric Biosciences Unveils EVM401 Series… preliminary testing… demonstrated differentiated and encouraging patterns of brain receptor binding and/or activation.” .
  • “We are pleased to enter into two licensing agreements… creating the potential for diversified future revenue streams.” — CEO commentary on Restoration Biologics .

Q&A Highlights

No Q1 2025 earnings call transcript was available; therefore, no analyst Q&A themes or clarifications could be assessed [ListDocuments returned none for earnings-call-transcript].

Estimates Context

  • S&P Global consensus EPS and revenue estimates for Q1 2025 were unavailable for ENVB; as a result, no beat/miss analysis versus Street can be provided (values not returned by S&P Global for Q1 2025).
  • Given pre-revenue status and development-stage focus, coverage may be limited; any future initiation of revenue or clinical milestones could increase estimate visibility [GetEstimates Q1 2025 returned no data].

Key Takeaways for Investors

  • IND timeline extended: EB-003 IND filing now targeted for end of Q1 2026, reducing near-term clinical catalysts versus prior expectations; monitor pre-IND interactions and study completions .
  • Liquidity improved but runway constrained: cash $4.29M at quarter-end, ATM program up to ~$1.85M; management disclosed going concern risk absent new capital; expect continued financing cadence and potential dilution .
  • IP moat strengthening: EB-003 NOA and EVM401 patent broaden proprietary coverage in neuroplastogens; supports longer-term asset value and partnering leverage .
  • Non-core monetization: multiple licensing deals (Aries, MycoMedica, Restoration Biologics) could create milestone/royalty optionality, albeit timing/realization uncertain; helpful for non-dilutive funding prospects .
  • Operating discipline: G&A down 28% YoY while R&D up to support IND package; expect spend mix to remain focused on EB-003 and enabling studies .
  • No Street consensus: estimates unavailable; price reactions likely tied to financing events, IP updates, and regulatory timelines rather than quarterly “beats/misses” [GetEstimates Q1 2025 returned no data].
  • Watch catalysts: additional patent grants, pre-IND feedback, new BD/licensing announcements, and financing execution are likely narrative drivers in the next 1–2 quarters .